Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) – Pipeline Review, H2 2016

Global Markets Direct’s, ‘Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) – Pipeline Review, H2 2016’, provides in depth analysis on Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted pipeline therapeutics.

The report provides comprehensive information on the Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22), targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics development and features dormant and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Drug profiles featured in the report undergoes periodic review following a stringent set of processes to ensure that all the profiles are updated with the latest set of information. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis.

The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage.

Note: Certain sections in the report may be removed or altered based on the availability and relevance of data.

Scope

The report provides a snapshot of the global therapeutic landscape for Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22)

The report reviews Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics under development by companies and universities/research institutes based on information derived from company and industry-specific sources

The report covers pipeline products based on various stages of development ranging from pre-registration till discovery and undisclosed stages

The report features descriptive drug profiles for the pipeline products which includes, product description, descriptive MoA, R&D brief, licensing and collaboration details & other developmental activities

The report reviews key players involved in Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics and enlists all their major and minor projects

The report assesses Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics based on mechanism of action (MoA), route of administration (RoA) and molecule type

The report summarizes all the dormant and discontinued pipeline projects

The report reviews latest news and deals related to Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) targeted therapeutics

Reasons to buy

Gain strategically significant competitor information, analysis, and insights to formulate effective R&D strategies

Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage

Identify and understand the targeted therapy areas and indications for Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22)

Identify the use of drugs for target identification and drug repurposing

Identify potential new clients or partners in the target demographic

Develop strategic initiatives by understanding the focus areas of leading companies

Plan mergers and acquisitions effectively by identifying key players and it’s most promising pipeline therapeutics

Devise corrective measures for pipeline projects by understanding Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC 2.7.11.22) development landscape

Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope

Companies mentioned

Beta Pharma, Inc.

Eli Lilly and Company

G1 Therapeutics, Inc.

Jiangsu Hengrui Medicine Co., Ltd.

Novartis AG

Onconova Therapeutics, Inc.

Pfizer Inc.

Presage Biosciences, Inc.

Sihuan Pharmaceutical Holdings Group Ltd.

Teijin Pharma Limited

Theryte Limited

Tiziana Life Sciences Plc

Vichem Chemie Research Ltd.

ViroStatics srl

Table of Contents

Table of Contents

Table of Contents 2

List of Tables 6

List of Figures 7

Introduction 8

Global Markets Direct Report Coverage 8

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) Overview 9

Therapeutics Development 10

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Products under Development by Stage of Development 10

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Products under Development by Therapy Area 11

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Products under Development by Indication 12

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Pipeline Products Glance 14

Late Stage Products 14

Early Stage Products 15

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Products under Development by Companies 16

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Therapeutics Assessment 21

Assessment by Monotherapy/Combination Products 21

Assessment by Mechanism of Action 22

Assessment by Route of Administration 23

Assessment by Molecule Type 25

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Companies Involved in Therapeutics Development 27

Beta Pharma, Inc. 27

Eli Lilly and Company 28

G1 Therapeutics, Inc. 29

Jiangsu Hengrui Medicine Co., Ltd. 30

Novartis AG 31

Onconova Therapeutics, Inc. 32

Pfizer Inc. 33

Presage Biosciences, Inc. 34

Sihuan Pharmaceutical Holdings Group Ltd. 35

Teijin Pharma Limited 36

Theryte Limited 37

Tiziana Life Sciences Plc 38

Vichem Chemie Research Ltd. 39

ViroStatics srl 40

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Drug Profiles 41

abemaciclib - Drug Profile 41

Product Description 41

Mechanism Of Action 41

R&D Progress 41

BPI-1178 - Drug Profile 46

Product Description 46

Mechanism Of Action 46

R&D Progress 46

C-1748 - Drug Profile 47

Product Description 47

Mechanism Of Action 47

R&D Progress 47

FLX-925 - Drug Profile 49

Product Description 49

Mechanism Of Action 49

R&D Progress 49

G-1T28 - Drug Profile 50

Product Description 50

Mechanism Of Action 50

R&D Progress 50

G-1T38 - Drug Profile 52

Product Description 52

Mechanism Of Action 52

R&D Progress 52

GZ-381 - Drug Profile 53

Product Description 53

Mechanism Of Action 53

R&D Progress 53

milciclib - Drug Profile 54

Product Description 54

Mechanism Of Action 54

R&D Progress 54

MMD-37K - Drug Profile 56

Product Description 56

Mechanism Of Action 56

R&D Progress 56

ON-123300 - Drug Profile 57

Product Description 57

Mechanism Of Action 57

R&D Progress 57

palbociclib - Drug Profile 58

Product Description 58

Mechanism Of Action 58

R&D Progress 58

ribociclib succinate - Drug Profile 68

Product Description 68

Mechanism Of Action 68

R&D Progress 68

SHR-6390 - Drug Profile 72

Product Description 72

Mechanism Of Action 72

R&D Progress 72

Small Molecule to Inhibit CDK 4 and 6 for Rheumatoid Arthritis - Drug Profile 73

Product Description 73

Mechanism Of Action 73

R&D Progress 73

Small Molecule to Inhibit CDK4 and CDK6 for Acute Kidney Injury and Breast Cancer - Drug Profile 74

Product Description 74

Mechanism Of Action 74

R&D Progress 74

Small Molecule to Inhibit CDK4 and CDK6 for Breast Cancer - Drug Profile 75

Product Description 75

Mechanism Of Action 75

R&D Progress 75

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HPV Associated Cancers - Drug Profile 76

Product Description 76

Mechanism Of Action 76

R&D Progress 76

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for HSV Infections - Drug Profile 77

Product Description 77

Mechanism Of Action 77

R&D Progress 77

Small Molecule to Inhibit CDK4, CDK6 and CDK9 for Oncology - Drug Profile 78

Product Description 78

Mechanism Of Action 78

R&D Progress 78

Small Molecules to Inhibit CDK4 for Oncology - Drug Profile 79

Product Description 79

Mechanism Of Action 79

R&D Progress 79

Small Molecules to Inhibit CDK4, CDK6 and CDK9 for EBV Infections - Drug Profile 80

Product Description 80

Mechanism Of Action 80

R&D Progress 80

THR-53 - Drug Profile 81

Product Description 81

Mechanism Of Action 81

R&D Progress 81

voruciclib - Drug Profile 82

Product Description 82

Mechanism Of Action 82

R&D Progress 82

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Dormant Projects 84

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Discontinued Products 86

Cyclin Dependent Kinase 4 (Cell Division Protein Kinase 4 or PSK J3 or CDK4 or EC

2.7.11.22) - Featured News & Press Releases 87

Jul 06, 2016: Study Tests New Breast Cancer Drug In African American Women 87

Jun 03, 2016: Presage Biosciences Appoints David Johnson to Board of Directors 88

Jun 03, 2016: Lilly Announces Results From MONARCH 1 Trial Of Abemaciclib Monotherapy 88

May 31, 2016: Lilly Announces Webcast To Discuss Abemaciclib Data 89

May 23, 2016: Investigational CDK4/6 inhibitor abemaciclib is active against a range of cancer types 89

May 18, 2016: Eli Lilly to Present final phase 2 monotherapy data on CDK 4 and 6 inhibitor abemaciclib in metastatic breast cancer at ASCO 91

May 18, 2016: MONALEESA-2 trial of Novartis' LEE011 (ribociclib) stopped due to positive efficacy results at interim analysis in HR+/HER2- advanced breast cancer 92

May 10, 2016: Health Canada approves new first-line treatment for women living with metastatic breast cancer 92

Apr 20, 2016: Onconova Announces Novel Dual Targeting of ARK5 and CDK4/6 by Pre-clinical Compound, ON 123300, in Presentation at 2016 American Association of Cancer Research (AACR) Annual Meeting 94

Apr 19, 2016: Presage Biosciences Presents Data Demonstrating Tumor Growth Inhibition by Voruciclib and Proteasome Inhibitors Superior to Single Agents in Model of Triple Negative Breast Cancer 94

Apr 19, 2016: Pfizer Announces Positive Top-Line Results For Phase 3 PALOMA-2 Clinical Trial Of IBRANCE (Palbociclib) 95

Apr 15, 2016: G1 Therapeutics to Present Preliminary clinical data on CDK4/6 Inhibitor G1T28 at the 2016 American Association for Cancer Research Annual Meeting 97

Apr 15, 2016: G1 Therapeutics to Present Preclinical Data on CDK4/6 Inhibitor G1T38 at the 2016 American Association for Cancer Research Annual Meeting 98

Mar 14, 2016: New agent overcomes drug resistance in HER2-positive breast cancer preclinical study shows 98

Mar 07, 2016: New therapeutic target in myeloma discovered 100

Appendix 101

Methodology 101

Coverage 101

Secondary Research 101

Primary Research 101

Expert Panel Validation 101

Contact Us 101

Disclaimer 102

List of Tables

List of Tables

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Number of Products under Development by Companies, H2 2016 16

Products under Development by Companies, H2 2016 17

Products under Development by Companies, H2 2016 (Contd..1) 18

Products under Development by Companies, H2 2016 (Contd..2) 19

Products under Development by Companies, H2 2016 (Contd..3) 20

Assessment by Monotherapy/Combination Products, H2 2016 21

Number of Products by Stage and Mechanism of Action, H2 2016 22

Number of Products by Stage and Route of Administration, H2 2016 24

Number of Products by Stage and Molecule Type, H2 2016 26

Pipeline by Beta Pharma, Inc., H2 2016 27

Pipeline by Eli Lilly and Company, H2 2016 28

Pipeline by G1 Therapeutics, Inc., H2 2016 29

Pipeline by Jiangsu Hengrui Medicine Co., Ltd., H2 2016 30

Pipeline by Novartis AG, H2 2016 31

Pipeline by Onconova Therapeutics, Inc., H2 2016 32

Pipeline by Pfizer Inc., H2 2016 33

Pipeline by Presage Biosciences, Inc., H2 2016 34

Pipeline by Sihuan Pharmaceutical Holdings Group Ltd., H2 2016 35

Pipeline by Teijin Pharma Limited, H2 2016 36

Pipeline by Theryte Limited, H2 2016 37

Pipeline by Tiziana Life Sciences Plc, H2 2016 38

Pipeline by Vichem Chemie Research Ltd., H2 2016 39

Pipeline by ViroStatics srl, H2 2016 40

Dormant Projects, H2 2016 84

Dormant Projects (Contd..1), H2 2016 85

Discontinued Products, H2 2016 86

List of Figures

List of Figures

Number of Products under Development for, H2 2016 10

Number of Products under Development by Therapy Area, H2 2016 11

Number of Products under Development by Top 10 Indication, H2 2016 12

Comparative Analysis by Late Stage Development, H2 2016 14

Comparative Analysis by Early Stage Products, H2 2016 15

Assessment by Monotherapy/Combination Products, H2 2016 21

Number of Products by Stage and Mechanism of Actions, H2 2016 22

Number of Products by Routes of Administration, H2 2016 23

Number of Products by Stage and Routes of Administration, H2 2016 23

Number of Products by Molecule Types, H2 2016 25

Number of Products by Stage and Molecule Type, H2 2016 25

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